Flowonix Prometra Programmable Pump Recalled for Unexpected Shutdowns
Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may fail to deliver medication, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Flowonix Medical Inc. is recalling 809 units of the Prometra Programmable Pump, Catalog Number 11827, which is used for intrathecal infusion. The recall is due to a software defect that can cause the pump to shut down unexpectedly if Error 115 is triggered.
The increase in Error 115 occurrences is associated with a watchdog timer timeout. This error is caused by a software defect that occurs when a Healthcare Provider uses a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.
The affected pumps were distributed nationwide in the United States. Consumers and healthcare providers should check their pump serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
- Manufacturer
- Flowonix Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 809
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Flowonix Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Flowonix Medical Inc
See all →- HighInfusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions
FDA (Devices) · 2021-07-07
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Defect
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighFlowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Anomaly
FDA (Devices) · 2020-02-19
- HighFlowonix Prometra II Pump Recall for Firmware Alarm Defect
FDA (Devices) · 2020-02-19
- HighFlowonix US Clinical 20mL Programmable Pump Recall for Firmware Alarm Defect
FDA (Devices) · 2020-02-19
- CriticalFlowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI
FDA (Devices) · 2017-07-26